FDA: We can't prevent another Vioxx

Official says agency is 'virtually defenseless' at hearing

LauraGilcrest

WASHINGTON (CBS.MW) -- A Food and Drug Administration official told lawmakers Thursday that the agency, in its current form, is unable to protect the public from another Vioxx-type incident.

A clinical study showed increased cardiac risk linked to long-term use of the Merck arthritis drug and painkiller Vioxx.

David Graham, associate director for science and medicine in the FDA's Office of Drug Safety and the drug reviewer who first warned of a Vioxx danger, told members of the Senate Finance Committee that the agency as currently configured "is incapable of protecting Americans against another Vioxx."

"We are virtually defenseless," Graham said.

Graham, other public health officials and Merck Chief Executive Raymond Gilmartin are testifying before the Senate panel, which is investigating whether the Merck
MRK, -0.39%
drug should have been pulled from the market more quickly when an increased cardiac risk became apparent.

Graham told lawmakers that much of the blame for the Vioxx incident lies with the FDA's Center for Drug Evaluation and Research, or CDER.

"When a serious safety issue arises post-marketing, their immediate reaction is almost always one of denial, rejection and heat," he said.

The prevailing atmosphere at CDER is that "they approved the drug, so there can't possibly be anything wrong with it." Graham added that the same group responsible for approving a drug at the FDA is later charged with taking regulatory action against it if need be. He labeled the situation an "inherent conflict of interest."

"FDA has let the American public down," he told the committee.

Naming names

Graham also warned of potential risks to users of a number of other drugs that are currently being prescribed. For example, Graham said, the agency should take a serious look at the recently approved lipid-lowering drug Crestor, made by AstraZeneca
AZN, -0.10%
which he said appears to have a risk of renal failure.

That caused the company's shares to drop 9 percent to $40.15 in late trading.

He pointed out that there are already a number of other drugs in Crestor's class -- so-called statins -- on the market that do not pose such a risk. Another example is the Pfizer
PFE, -0.25%
arthritis drug Bextra, which, according to Graham, "needs good studies of cardiac risk." Pfizer was down 11 cents to $27.88.

In the case of GlaxoSmithKline's
GSK, +0.08%
asthma treatment Serevent, Graham said the FDA approved the drug even though a study in the United Kingdom pointed to a possible increased risk of respiratory failure.

He explained that the FDA had asked Glaxo for a bigger study to more clearly understand that potential danger, but he said that the firm canceled that study and the drug remains on the market. Glaxo shares lost 3.4 percent to $43.50.

"There is no magic formula" for ensuring drugs' safety, she told lawmakers.

Committee members pressed Kweder on whether the agency should have an independent body review new drugs once they're on the market, similar to the system used in Europe.

Kweder said that is among the issues the FDA has asked the Institute of Medicine to review as the agency seeks to improve its drug-monitoring system.

In defense of Merck

Kweder also insisted that Merck "acted responsibly" once the problem with Vioxx became apparent. Merck voluntarily withdrew it from the market on Sept. 30.

Merck's Gilmartin said in prepared testimony to lawmakers that the firm had withdrawn Vioxx from the market just days after a clinical study showed increased cardiac risk linked to long-term use of the widely prescribed drug.

Leading up to those findings, he added, data from controlled clinical trials had indicated no higher cardiac risk with Vioxx compared with a placebo and with other nonsteroidal anti-inflammatory drugs (NSAIDs) other than naproxen.

Gilmartin also told lawmakers that Merck promptly disclosed results of company-sponsored studies to FDA physicians and the media after Vioxx's approval in the late 1990s.

Commenting on epidemiology studies that pointed to an increased heart risk, the executive said that those studies have an important role to play but are less persuasive than controlled clinical trials.

Gilmartin also told the lawmakers that Vioxx's higher cardiac risks were not apparent in the company's study database of about 28,000 patients before the time frame of 18 months.

Those studies had compared Merck's drug with placebos or with other NSAIDs other than naproxen.

The company first became aware of the increased heart risk during a long-term study -- the so-called Approve study - done to test Vioxx for its use in preventing colon polyps, he said..

He also stressed that the study led by FDA's Graham played no role in Merck's decision to recall Vioxx.

Gilmartin said that Vioxx's recall underscored the importance of post-market monitoring of drugs for serious side effects, as well as the need for companies to disclose the positive and negative results of their clinical trials.

Senate committee to keep pursuing

Committee Chairman Sen. Charles Grassley, R-Iowa, said that his committee would ask the General Accountability Office to look into FDA's system for assuring the safety of drugs and the Senate committee would continue its own probe into the Vioxx matter.

Grassley said the highly publicized recall points to the need for an independent body to monitor the safety of drugs after they hit the market.

Since Vioxx's recall, many lawmakers have criticized the FDA for not paying closer attention to various clinical data over the years that indicated Vioxx could cause heart problems.

The agency eventually hired expert cardiologists to review much of Vioxx's cardiovascular data, the results of which were released in August through Kaiser Permanente.

The Thursday hearing is just the latest of Merck's legal woes. Two other congressional committees -- the House Committee on Government Reform and the Senate Committee on Health, Education, Labor and Pensions -- also have made inquiries into the matter.

Meanwhile, Merck has become the target of hundreds of lawsuits filed by former Vioxx users who claim they've been injured, as well as shareholders who claim they were misled by the company. Merck is also being probed by several state attorneys general, the Justice Department and the Securities and Exchange Commission.

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